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Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02788071
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : August 2, 2017
Sponsor:
Collaborators:
Hvidovre University Hospital
University of Aarhus
Information provided by (Responsible Party):
Alice Højer Christensen, Aleris-Hamlet Hospitaler København

Study Description
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Brief Summary:
The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: FMT capsules Dietary Supplement: FMT placebo Phase 2 Phase 3

Detailed Description:

Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal condition. IBS is associated with a high use of health-care costs and can substantially reduce quality of life and work productivity.

Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls.

Fecal microbiota transplantation (FMT) could therefore be a treatment option for IBS patients by exchanging the microbiota of an IBS patient with the microbiota of a healthy donor.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome (IBS) - a Randomized, Double-blind Placebo Controlled Pilot Study
Study Start Date : October 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Experimental: FMT capsules
FMT capsules
 Dietary Supplement: FMT capsules
25 capsules per day for 12 days
Placebo Comparator: FMT placebo
Placebo capsules
 Dietary Supplement: FMT placebo
25 capsules per day for 12 days


Outcome Measures
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Primary Outcome Measures :
  1. symptoms score [ Time Frame: 12 weeks ]
    Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)


Secondary Outcome Measures :
  1. Change in microbiota diversity [ Time Frame: Day 4, 4 weeks, 12 weeks and 24 weeks ]
    Measured by DNA sequencing

  2. Microbiota diversity IBS patients [ Time Frame: Baseline ]
    Measured by DNA sequencing

  3. Microbiota diversity in healthy donors [ Time Frame: Baseline ]
    Measured by DNA sequencing. To compare with the recipients (IBS patients)

  4. Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfilled Rome III diagnostic criteria for IBS
  • Moderate-severe disease activity (IBS-Symptom Severity Score ≥175)
  • Able to read and speak Danish
  • Normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool

Exclusion Criteria:

  • Other chronic gastrointestinal disease
  • Positive fecal sample with enteropathogenic microorganisms or Clostridium difficile
  • Positive screening for HIV, Hepatitis B or HCV antibody
  • Surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures)
  • Psychiatric disorder
  • Fecal calprotectin ≥ 50 mg/kg
  • Abuse of alcohol or drugs
  • Medications other than birth control pills, hormone supplements, allergies and asthma agents, blood pressure and cholesterol lowering agents, proton pump inhibitors and non-prescription medicines
  • Abnormal screening biochemistry
  • Abnormal colonoscopy findings
  • Pregnant, planned pregnancy or breastfeeding females
  • Ingestion of probiotics or antibiotics < 8 weeks before the inclusion

Inclusion criteria for donors

  • Age between 18-45 years
  • Past and current healthy
  • Normal weight (BMI between 18,5-24,9 kg/m2)
  • Normal bowel movements (defined as 1-2 per day and type 3-4 at Bristol Stool Form Scale)
  • No medication consumption

Exclusion criteria for donors

  • Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
  • Positive stool sample for C. difficile toxin, parasites or other pathogens
  • Antibiotic treatment in the past 6 months
  • Abuse of alcohol or drugs
  • Smoking
  • Tattoo or body piercing within the last 6 months
  • Allergy, asthma or eczema
  • Family history of gastrointestinal diseases
  • Participation in high-risk sexual behaviors
  • Born by Caesarean section
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788071


Locations
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Denmark
Aleris Hamlet Hospitaler, København
Copenhagen, Søborg, Denmark, 2760
Sponsors and Collaborators
Aleris-Hamlet Hospitaler København
Hvidovre University Hospital
University of Aarhus
Investigators
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Principal Investigator: Alice Højer Christensen, MD, PhD Aleris-Hamlet Hospitaler København
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alice Højer Christensen, MD, PhD, Aleris-Hamlet Hospitaler København
ClinicalTrials.gov Identifier: NCT02788071    
Other Study ID Numbers: H-15016343
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Alice Højer Christensen, Aleris-Hamlet Hospitaler København:
Irritable Bowel Syndrome
Fecal Microbiota Transplantation
Microbiota
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases